Revlimid
These highlights do not include all the information needed to use REVLIMID safely and effectively. See full prescribing information for REVLIMID. REVLIMID (lenalidomide) capsules, for oral useInitial U.S. Approval: 2005
Approved
Approval ID
5fa97bf5-28a2-48f1-8955-f56012d296be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 24, 2023
Manufacturers
FDA
Celgene Corporation
DUNS: 174201137
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lenalidomide
PRODUCT DETAILS
NDC Product Code59572-402
Application NumberNDA021880
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 31, 2021
Generic NameLenalidomide
INGREDIENTS (5)
LENALIDOMIDEActive
Quantity: 2.5 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lenalidomide
PRODUCT DETAILS
NDC Product Code59572-425
Application NumberNDA021880
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 31, 2021
Generic NameLenalidomide
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LENALIDOMIDEActive
Quantity: 25 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Lenalidomide
PRODUCT DETAILS
NDC Product Code59572-420
Application NumberNDA021880
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 31, 2021
Generic NameLenalidomide
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LENALIDOMIDEActive
Quantity: 20 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lenalidomide
PRODUCT DETAILS
NDC Product Code59572-410
Application NumberNDA021880
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 31, 2021
Generic NameLenalidomide
INGREDIENTS (5)
LENALIDOMIDEActive
Quantity: 10 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lenalidomide
PRODUCT DETAILS
NDC Product Code59572-415
Application NumberNDA021880
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 31, 2021
Generic NameLenalidomide
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LENALIDOMIDEActive
Quantity: 15 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
Lenalidomide
PRODUCT DETAILS
NDC Product Code59572-405
Application NumberNDA021880
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateAugust 31, 2021
Generic NameLenalidomide
INGREDIENTS (5)
LENALIDOMIDEActive
Quantity: 5 mg in 1 1
Code: F0P408N6V4
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT